NCT06165900招募中2 期
A Multicenter, Randomized Trial of Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) Versus Adebrelimab Combined With TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of Triple-negative Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- tpCR
研究概览
简要总结
This study was an open-label, multicenter, randomized study. It is planned to include 136 patients with stage II-III triple negative breast cancer. Eligible subjects will be randomized to receive either the experimental arm: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) or the control arm: adebrelimab plus nab-paclitaxel + carboplatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Treatment-naïve breast cancer female patients aged ≥ 18 years and ≤ 75 years;
- •Histopathologically confirmed early or locally advanced triple-negative invasive breast cancer according to the latest ASCO/CAP guidelines, meeting the following conditions: (1) pathological type is triple-negative, specifically: ER negative: IHC < 1%, PR negative: IHC < 1%, HER2 negative: IHC 0/1 + or IHC2 + but ISH negative;
- •Clinical stage II-III invasive breast cancer with measurable lesions according to RECIST 1.1;
- •ECOG score 0-1;
- •Able to tolerate preoperative and postoperative adjuvant radiotherapy after assessment by a radiologist;
- •Appropriate level of organ function
- •Patients voluntarily participate in and sign the informed consent form, are expected to have good compliance and cooperate with the study according to the requirements of the protocol.
排除标准
- •Patients with metastatic breast cancer or bilateral breast cancer;
- •Patients with inflammatory breast cancer or occult breast cancer;
- •Patients received any anti-tumor therapy within 12 months before signing the informed consent form, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy or tumor embolization;
- •Patients previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or other treatments against PD-1/PD-L1 inhibitors;
- •Female patients who are pregnant and lactating, female patients who are fertile and have a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial.
- •Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, and the subject has a known history of psychotropic drug abuse, alcoholism ;
- •Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); positive hepatitis B surface antigen (HBsAg) test, or positive hepatitis B core antibody (HBcAb) test followed by positive HBV-DNA test (HBV-DNA test was performed only in patients with negative HBsAg test and positive HBcAb test); positive hepatitis C virus (HCV) antibody test followed by positive HCV-RNA test (HCV-RNA test was performed only in patients with positive HCV antibody test)
- •Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.
研究组 & 干预措施
adebrelimab plus stereotactic radiotherapy and chemotherapy
Experimental
干预措施: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) (Drug)
adebrelimab plus nab-paclitaxel + carboplatin
Active Comparator
干预措施: adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) (Drug)
结局指标
主要结局
tpCR
时间窗: 6 months
total pathologic complete response
次要结局
未报告次要终点
研究者
Caigang Liu
Clinical Professor
Shengjing Hospital
研究点 (1)
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